QA Engineer

• Manage onboarding manufacturers of sourced finished medical device products to ensure products meet current Good Manufacturing Practices, applicable medical device regulatory requirements, and support business development initiatives
• Support supplier quality activities for sourced finished Medical Device products and lead these supplier audits in accordance with Olympus global supplier quality processes
• Qualify sourced finished Medical Device product suppliers by assessing the supplier capabilities through direct on-site visits and technical discussions
• Prepare Quality Assurance Agreements outlining the roles and responsibilities and relationship between Olympus and the suppliers
• Ensure regulatory and contractual compliance in accordance to FDA, ISO 13485, ISO 9001, MDSAP, EUMDR, and applicable regulations
• Develop quality assurance strategy for sourced products including incoming inspection requirements
• Identify gaps in suppliers' capabilities / technical project risks
• Review product specifications, component qualifications, design verification/validations, and process validations
• Lead and participate in Quality Assurance Business Development initiatives within cross-functional teams and capture subject matter expertise within the Business Development function
• Create and execute Quality Plans for projects such as onboarding new suppliers, product transfers, integration following mergers and acquisitions
• Work with cross-functional teams to support program architecture and ensure effective integration of new suppliers and their products into Olympus’ systems
• Ensure functional and regional alignment by coordinating with global and regional QA teams to ensure efforts are aligned, approvals are maintained, and resources are identified
• Build and maintain a network of resources in all regions, across all businesses and divisions
• Stay current on industry and functional trends by reviewing the output of relevant quality and regulatory intelligence reports and apply learning to target evaluation and integration

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